3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK

K121593 · 3M Company · FRC · Mar 15, 2013 · General Hospital

Device Facts

• Record ID: K121593
• Device Name: 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Mar 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Indications for Use

Use the 3M Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (pre-vacuum) steam sterilization cycles of 270°F (132°C) at 4 minutes and 275°F (135°C) at 3 minutes. The 3M Attest™ Super Rapid Readout Biological Indicator 1492V contained in the challenge pack provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.

Device Story

Challenge packs consist of medical index card layers, die-cut to house biological indicators (BI) and chemical integrators; overwrapped and labeled. Used in healthcare facilities to monitor steam sterilization efficacy. Input: steam exposure during sterilization cycle. BI contains Geobacillus stearothermophilus spores; if sterilization fails, spores metabolize, producing fluorescence detected by 3M Attest 490 Auto-reader within 1 hour. 41482V model includes SteriGage chemical integrator for immediate visual Accept/Reject reading, aiding emergency implant load release. External chemical process indicator changes color (yellow to brown) upon steam exposure. Output: fluorescent signal (BI) and visual color change (integrator/process indicator). Healthcare providers use results to verify sterilization cycle success; failure triggers immediate investigation of sterilization process before item release. Benefits: rapid sterility assurance, reduced wait times for surgical instruments.

Clinical Evidence

Bench testing only. Evaluated resistance against AAMI towel pack standards (ANSI/AAMI ST-79). Confirmed BI population ≥ 10^6 Geobacillus stearothermophilus spores. Verified chemical integrator compliance with ANSI/AAMI/ISO 11140-1 (Class 5). Confirmed external process indicator color change performance. No clinical data required.

Technological Characteristics

Challenge pack: medical index cards, die-cut, overwrapped. Biological indicator: Geobacillus stearothermophilus (ATCC 7953) spores. Chemical integrator: SteriGage (Class 5). External process indicator: yellow-to-brown color change. Connectivity: requires 3M Attest 490 Auto-reader for fluorescence detection. Standards: ANSI/AAMI/ISO 11138-1, 11138-3, 11140-1, 18472.

Indications for Use

Indicated for use in healthcare facilities to qualify or monitor dynamic-air-removal (pre-vacuum) steam sterilization cycles at 270°F (132°C) for 4 minutes and 275°F (135°C) for 3 minutes.

Regulatory Classification

Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

Predicate Devices

• 3M Attest™ Steam-Plus Pack (K925496)
• 3M Attest™ 1492V Super Rapid Readout Biological Indicator for Steam and 3M Attest™ 490 Auto-reader (K121484)

Submission Summary (Full Text)

{0}------------------------------------------------

## Premarket Notification (510(k)) Summary

# ЗМ

## Sponsor Information:

3M Health Care 3M Center, Bldg. 275-5W-06 . St. Paul, MN 55144-1000

| Contact Person: | Suzanne Leung, Ph.D., RAC<br>Regulatory Affairs Manager |
|-----------------|---------------------------------------------------------|
| Phone Number: | [phone] |
| FAX Number: | [phone] |

Date of Summary: March 14, 2013

## Device Name and Classification:

| Common or Usual Name: | Sterilization Biological Indicator |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | 3M Attest™ 1496V Super Rapid Readout Steam<br>Challenge Pack<br>3M Attest™ 41482V Super Rapid 5 Steam-Plus Challenge<br>Pack |
| Classification Name: | Indicator, Biological Sterilization Process<br>(21 CFR § 880.2800(a)) |
| Product Code: | FRC |
| Product Class: | Class II |

## Predicate Devices:

3M Attest™ Steam-Plus Pack, formerly AT1® Disposable Biological-Plus Test Pack cleared under K925496, acquired by 3M

3M Attest™ 1492V Super Rapid Readout Biological Indicator for Steam and 3M Attest™ 490 Auto-reader (K121484)

{1}------------------------------------------------

#### Description of Device:

The 3M Attest™ 1496V Super Rapid Readout Steam and 41482V Super Rapid 5 Steam-Plus Challenge Packs are specifically designed to qualify or routinely challenge 270°F (132°C) and 275°F (135°C) dynamic-air-removal (pre-vacuum) steam sterilization cycles in healthcare facilities.

#### Similarities to the predicate device

The 1496V and 41482V Challenge Packs are similar in design to the predicate device the 3M Attest™ Steam-Plus Pack. The packs consist of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The packs are overwrapped and secured with a label. The Challenge Packs and the predicate device all contain a biological indicator. The 41482V Challenge Pack and the predicate device also contain a SteriGage™ chemical integrator. The SteriGage™ integrator offers an immediate Accept/Reject reading that allows for implant load early release in emergency situations as defined in AAMI ST-79. Each Challenge Pack has a chemical process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam.

#### Differences from the predicate device

Each 1496V test pack contains an Attest™ 1492V Super Rapid Biological Indicator (1492V SRBI) while the 41482V Super Rapid 5 Steam-Plus Challenge Pack contains a 1492V SRBI and a SteriGage™ steam chemical integrator. The predicate device contains an Attes1™ 1262 Biological Indicator with a visual pH color change result at 48 hours and a SteriGage™ steam chemical integrator. The 1492V SRBI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M Attest™ 490 Auto-reader. A fluorescence change indicates a steam sterilization process failure. Attest™ 1492V SRBI controls are provided with the Challenge Packs.

| | Predicate Device<br>Attest™ Steam-Plus Pack | Attest™ 1496V<br>Challenge Pack | Attest™ 41482V<br>Challenge Pack |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------|
| General Design | Layers of medical index cards,<br>some of which are die-cut to<br>contain indicators, overwrapped<br>and secured with a label. | Same as Predicate | Same as Predicate |
| Biological<br>Indicator | Attest™ 1262 Biological<br>Indicator (48 hr visual pH color<br>change result) | Attest™ 1492V<br>Biological Indicator<br>(1 hour fluorescent<br>result) | Attest™ 1492V<br>Biological Indicator (1<br>hour fluorescent result) |
| Chemical<br>Integrator | SteriGage™ Chemical Integrator | No Chemical<br>Integrator | SteriGage™ Chemical<br>Integrator |
| External<br>Chemical<br>Process<br>Indicator | Yellow to brown color change<br>when exposed to steam | Same as Predicate | Same as Predicate |

#### Similarities and Differences between Challenge Packs and Predicate Device

{2}------------------------------------------------

### Indications for Use:

Use the 3M Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (pre-vacuum) steam sterilization cycles of 270°F (132°C) at 4 minutes and 275°F (135°C) at 3 minutes.

The 3M Attest™ Super Rapid Readout Biological Indicator 1492V contained in the challenge pack provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.

## Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:

Testing was conducted on the indicators and the challenge packs following the FDA guidance and standards below:

- FDA's Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket ● Notification [510(k)] Submissions; October 4, 2007
- FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators: . Guidance for Industry and FDA Staff, December 19, 2003
- ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products -Biological indicators - Part 1: General requirements
- ANSI/AAMI/ISO 11138-3: 2006/(R)2010 Sterilization of health care products -● Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
- . ANSI/AAMI/ISO 11140-1:2005/(R)2010 Sterilization of health care products -Chemical indicators, Part 1: General requirements
- ANSI/AAMI/ISO 18472:2006 Sterilization of health care products Biological and . chemical indicators: Test equipment
- United States Pharmacopeia, Chapter <1035> Biological Indicators for Sterilization and ● Chapter <55> Biological Indicators - Resistance Performance Tests.

140

- . ANSI/AAMI ST-79:2010, A1:2010 and A2:2011, Comprehensive guide to steam sterilization & sterility assurance in health care facilities

{3}------------------------------------------------

Multiple lots of 3M Attest™ Super Rapid Challenge Packs were prepared containing multiple lots of 1492V Super Rapid Bls and SteriGage™ chemical integrators. The Challenge Packs were evaluated against performance requirements below.

## Summary of Nonclinical Testing

| Challenge Pack Testing | Acceptance Criteria | Result |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Resistance of the Challenge<br>Pack as compared to AAMI<br>towel pack | Challenge Pack is at least as resistant as the biological indicator<br>AAMI towel pack recommended by ANSI/AAMI ST-79: 2010,<br>A1:2010 and A2:2011 | Pass |
| Resistance of the Pack as<br>compared to the Biological<br>Indicator or Chemical<br>Integrator alone | Pack provides a greater resistance than the Biological Indicator<br>or Chemical Integrator alone | Pass |
| Chemical Process Indicator | Chemical Process Indicator on the Challenge Pack label changes<br>from yellow to brown or darker upon exposure to steam | Pass |
| Characteristics of Biological<br>Indicator | Challenge Packs contain a biological indicator with Geobacillus<br>stearothermophilus (ATCCTM 7953) at a population ≥ 10^6<br>spores that complies with FDA's Guidance for Industry and<br>FDA Staff, Biological Indicator (BI) Premarket Notification<br>[510(k)] Submissions; October 4, 2007,<br>ANSI/AAMI/ISO 11138-1:2006/(R)2010 and ANSI/AAMI/ISO<br>11138-3: 2006/(R)2010 | Pass |
| Characteristics of Chemical<br>Integrator (41482V only) | Challenge Packs contain a chemical integrator that complies<br>with FDA's Guidance for Chemical Indicators FDA's<br>Premarket Notification [510(k)] Submissions for Chemical<br>Indicators: Guidance for Industry and FDA Staff, December<br>19, 2003 and ANSI/AAMI/ISO 11140-1:2005/(R)2010. Class 5 | Pass |

The results of these evaluations showed that the 3M Attest™ 1496V and 41482V Super Rapid Challenge Packs present a challenge to the sterilization process equivalent to the biological indicator AAMI towel pack recommended by ANSI/AAMI ST-79 Comprehensive guide to steam sterilization & sterility assurance in health care facilities.

## Conclusion

The 3M Attest™ 1496V and 41482V Super Rapid Challenge Packs and the 3M Attest™ 490 Auto-reader meet all applicable voluntary performance standards and are substantially equivalent to the predicate device in terms of their intended use, physical properties and technological characteristics. There are no new questions of safety or effectiveness.

141

{4}------------------------------------------------

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

March 15, 2013

Suzanne Leung, Ph.D., RAC Regulatory Affairs Manager 3M Company 3M Center, Building 275-5W-06 ST. PAUL MN 55144-1000

Re: K121593

Trade/Device Name: 3M Attest™ 1496V Super Rapid Readout Steam Challenge Pack 3M Attest™ 41482V Super Rapid 5 Steam-Plus Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: March 1, 2013 Received: March 4, 2013

Dear Dr. Leung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 - Dr. Leung

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

#### K121593 510(k) Number:

Device Name:

3M Attest™ 1496V Super Rapid Readout Steam Challenge Pack 3M Attest™ 41482V Super Rapid 5 Steam-Plus Challenge Pack

#### Indications for Use:

Use the 3M Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M Attest™ Super Rapid 5 Steam-Plus Steam Challenge Pack 41482V in conjunction with the 3M Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (pre-vacuum) steam sterilization cycles of 270°F (132°C) at 4 minutes and 275°F (135°C) at 3 minutes.

The 3M Attest™ Super Rapid Readout Biological Indicator 1492V contained in the challenge pack provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.

Prescription Use

AND/OR

Over-The-Counter Use X

C

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth 2013.03.12

(Division Sign-Off) mesthestology, General Hospital Infection Control, Den

510(k) Number: K121593